Building Online Community for Parkinson’s Palliative Care

Brief Title

Community Outreach for Palliative Engagement -- Parkinson Disease

Official Title

Building Online Community to Improve Patient and Caregiver Outcomes in Parkinson Disease, Lewy Body Dementia and Related Disorders

Brief Summary

      The purpose of this study is to learn more about the effectiveness of palliative care
      training for community physicians and telemedicine support services for patients and
      carepartners with Parkinson's disease and Lewy Body Dementia (LBD) or related conditions and
      their care partners. Palliative care is a treatment approach focused on improving quality of
      life by relieving suffering in the areas of physical symptoms such as pain, psychiatric
      symptoms such as depression, psychosocial issues and spiritual needs. Telemedicine is the use
      of technology that allows participants to interact with a health care provider without being
      physically near the provider.
    

Detailed Description

      Investigators propose to conduct a pragmatic stepped-wedge comparative effectiveness trial
      comparing a novel model of providing community-based palliative care for persons living with
      Parkinson's disease (PD), Lewy Body Dementia (LBD) and related disorders through online
      communities to usual care. Our intervention includes support for both community neurologists
      (using the ECHO model of clinician support) as well as family caregivers and patients.
      Investigators hypothesize that this model of care will improve patient quality of life and
      caregiver burden as well as other important secondary outcomes such as patient symptom burden
      and clinician burnout. This study will recruit neurology providers (MD and APPs) from 24
      community neurology practices. These practices will identify participants for the study who
      have PD, LBD or a related condition and moderate to high palliative care needs. Under usual
      care, community providers will deliver their usual care and center coordinators will collect
      data on our outcomes every 3 months. After one year of baseline data collection, 6 practices
      will be randomized to the intervention, which will include clinician training and coaching as
      well as access to online services for their patients. Per the stepped-wedge design an
      additional six practices will be randomized 18 months into the data collection period, six at
      24 months, and the final six will enter the intervention 30 months into the data collection
      period to allow for 12 months intervention recruitment for all practices.
    

Study Type

Interventional

Primary Outcome

Quality of Life: Alzheimer's Disease (QOL-AD)

Secondary Outcome

 Patient Measures Edmonton Symptom Assessment Scale

Condition

Parkinson Disease Dementia

Intervention

Parkinson Disease Standard Care

Study Arms / Comparison Groups

 Usual Care

Description:  Community neurologists provide their usual care to enrolled participants. The clinicians may utilize other community resources to support patients and families as per their usual practice.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

710

Start Date

April 26, 2022

Completion Date

August 31, 2026

Primary Completion Date

February 28, 2026

Eligibility Criteria

        Inclusion Criteria:

        PATIENT INCLUSION CRITERIA:

        • Over age 40 years and diagnosed with PD or other causes of parkinsonism, such as
        progressive supranuclear palsy, multiple system atrophy and Lewy Body Dementia by their
        community neurologist.

        Exclusion Criteria:

        PATIENT EXCLUSION CRITERIA:

          -  Potential patient subjects who are unable or unwilling to commit to study procedures

          -  Presence of additional medical illnesses which requires palliative services (e.g.
             metastatic cancer)

          -  Already receiving palliative care or hospice services.
      

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Benzi Kluger, MD, 585-275-2529, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT05222386

Organization ID

STUDY6775

Responsible Party

Principal Investigator

Study Sponsor

University of Rochester

Collaborators

 University of Colorado, Denver

Study Sponsor

Benzi Kluger, MD, Principal Investigator, University of Rochester

Verification Date

May 2022